⚠️ 510(k) RTAs are at a 5-year high. Substantial equivalence arguments are the #1 rejection reason. Don't guess — use the same framework cleared devices use.
510(k) Substantial Equivalence Toolkit
Stop guessing what FDA wants in your SE argument. Six templates that cover predicate selection, the five-step SE determination, technological differences analysis, and final submission checklist — structured exactly how FDA reviewers evaluate them.
Complete toolkit — instant download
$347
6 documents • 510(k) SE templates • FDA-aligned structure
What's Included
Predicate Device Comparison Table
Side-by-side comparison template for intended use, indications, technology, and performance characteristics vs. predicate device. Structured to match FDA reviewer expectations for 510(k) Section 11 (Substantial Equivalence).
Substantial Equivalence Summary Template
Complete SE summary template aligned with FDA 21 CFR 807.92 and CDRH 510(k) guidance. Covers the five-step SE determination pathway: intended use comparison, technology comparison, performance data adequacy, and final SE conclusion.
Performance Testing Matrix
Master matrix linking device performance characteristics to applicable FDA standards, test methods, and acceptance criteria. Pre-populated with common standards: ASTM, ISO, IEC, and FDA guidance-specific tests.
Technological Differences Analysis Template
Structured analysis for documenting that technological differences do not raise new safety or effectiveness questions. Includes risk-based rationale framework and scientific literature citation format FDA expects.
Intended Use and Indications for Use Statement Template
Correctly structured IFU/IU statement templates with examples. Covers the distinction FDA requires between intended use (general) and indications for use (specific patient population and disease state).
Substantial Equivalence Declaration Checklist
21-point final checklist confirming your SE argument covers all required elements before submission: predicate selection rationale, performance data complete, labeling consistent with SE claim, and 510(k) summary or statement prepared.
Frequently Asked Questions
What makes a strong predicate device selection?
A strong predicate has the same intended use, similar technology or equivalent performance data for differences, and an established FDA clearance record. Avoid predicates with recalls or troubled regulatory histories.
Can I use multiple predicates?
Yes. Split predicates are allowed — one for intended use and one for technology. The SE argument must show the combination is still substantially equivalent to a legally marketed device.
What if my device has technological differences from the predicate?
Technological differences are fine if you can demonstrate they do not raise new safety or effectiveness questions. The differences analysis template covers exactly this argument with the evidence structure FDA expects.